- Sanofi and Regneron have won an expanded U.S. approval for Dupixent in asthma, securing another indication for the biologic drug which the companies are counting on to deliver blockbuster sales.
- On Friday, the Food and Drug Administration OK'd the drug for moderate-to-severe asthma patients with an eosinophilic phenotype, or with oral corticosteroid-dependent asthma regardless of phenotype, the companies said. The new indication adds to Dupixent's previously approved use for moderate-to-severe atopic dermatitis.
- Clinical results supporting the approval showed Dupixent cut severe asthma attacks by 67% compared to placebo in patients with high eosinophil counts. Among patients with lower levels of the inflammation marker, however, Dupixent did not separate from placebo in statistical comparison.
Analysts project multi-billion dollar annual revenue for Dupixent in the coming years, and count the drug as crucial to Regeneron and Sanofi's bottom lines.
Those lofty goals remain a ways off, however. So far in 2018, Dupixent's earned $320 million in sales reported by Sanofi.
In a recent note, Raymond James analyst Laura Chico pointed to Dupixent's expansion into moderate asthma as key to the drug's achievement of Sanofi and Regeneron's sales goals.
Dupixent will face stiffer competition in asthma, however.
Teva's Cinqair (reslizumab) was approved in the U.S. for eosinophilic asthma in 2016, while GlaxoSmithKline's Nucala (mepolizumab) and AstraZeneca's Fasenra (benralizumab) picked up U.S. approval for the same indication in 2017.
In the pipeline, AstraZeneca and Amgen's tezepelumab is looking positive for eosinophilic asthma, as well as a broader range of asthma indications.
And it's not just competition that will challenge the drug — Dupixent has faced some market access pushback due to its price point.
Prior to Dupixent's approval, the Institute for Clinical and Economic Review concluded that the drug's expected annual list price of $36,000 for asthma would need substantial discounts of 68% to fall below the group's cost-effectiveness threshold.
In atopic dermatitis, the National Institute for Health and Care Excellence, the U.K.'s cost-effectiveness agency, said that while the drug was a step-change in treating moderate-to-severe atopic dermatitis, it wasn't sufficiently cost-effective at roughly 1,265 euros for a pair of syringes.